1. Field of the Invention
The present invention generally relates to the collecting of cell specimens from a body cavity for diagnostic purposes and, more particularly, is concerned with a cytologic sampling device for collecting both cervical and vaginal cell specimens.
2. Description of the Prior Art
Uterine cervical cancer can be prevented and possibly cured if it is detected early enough, preferably in its precancerous or precursor stages. For this reason, women are encouraged to have examinations on a regular basis. Improvements in early detection devices and techniques will enhance a physician's ability to accurately detect the presence of cancer in its early stages. Accordingly, much effort has been directed to developing such devices.
Bergeron et al in an article entitled "Screening devices for cervical and endometrial Ca", published in Contemporary OB/GYN (1987), present an extensive listing of cervical cytologic sampling and screening devices, including wooden spatulas and brushes, and also discuss how the devices should be used to effectively detect the presence of cancer and its precursors. Examples of such devices are also disclosed in U.S. patents to MacLean (U.S. Pat. No. 2,955,591), Antonides (U.S.Pat. No. 3,626,470), Oster (U.S. Pat. No. 3,815,580), Vermes (U.S. Pat. No. 3,877,464), Levene (U.S. Pat. No. 3,881,464), Nollan (U.S. Pat. No. 4,127,113), Kist (U.S. Pat. No. 4,700,713), Bayne (U.S. Pat. No. 4,754,764), Bayne et al (U.S. Pat. No. 4,762,133) and Bayne (U.S. Pat. No. 4,754,764 and 4,873,992).
For a cytologic device to be an effective means to use in sampling and collecting cell specimens for detecting cervical cancer and its precursors, basic criteria must be met. The cytologic device must be simple, easy and quick to use. Also, the device must be accurate, relatively painless, devoid of complications, and relatively inexpensive. While the currently-used devices undoubtedly work as intended, none meet all of the above-mentioned basic criteria.
Also, some devices are susceptible of providing a sample which results in a false negative diagnosis, that is, the specimen which appears to be free of aberrant or malignant cells when in fact such cells are actually present but are not detected. A false negative diagnosis may result when the devices fail to collect the cells or when such cells are collected but not readable, either because they are obscured by the mucus secretions obtained concurrently with the cells or because the cells cannot be adequately stained and accurately read.
Consequently, a need still exists for a cytologic sampling device which more nearly meets the above basic criteria and avoids the susceptibility of providing false negative samples.